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HealthyPhase 1NCT03446274

An Open Label, Single-Dose Study of 14C-NW-3509 in Healthy Male Subjects

A Phase 1 study testing Evenamide in people with Healthy, run by Newron Pharmaceuticals SPA at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-center, open-label, non-randomized, single dose of 14C-NW-3509 capsule study in 6 healthy male subjects. Read more about this study

Who is it for?
Ages 30 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Evenamide
Type of treatment
Pill or oral medicine
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
2 Apr 2018to Jun 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males
  • Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  • Must be willing and able to communicate and participate in the whole study
  • Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
  • Subject is considered healthy on the basis of medical history, physical examination, ECG, vital signs and clinical laboratory assessments
  • Must provide written informed consent
  • Must adhere to the contraception requirements

Who cannot join

  • Subjects who have received any IMP in a clinical research study within the previous 3 months
  • Subjects who are study site employees, or immediate family members of a study site or sponsor employee
  • Subjects who have previously been enrolled in this study
  • History of any drug or alcohol abuse in the past 2 years
  • Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
  • Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and admission
Show all 20Show fewer
  • Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
  • Radiation exposure, excluding background radiation but including significant medical exposures, or other trial related exposures, not exceeding 5 mSv in the 12 months preceding participation in the trial, or radiation exposure exceeding 10 mSv in the 5 years preceding participation in the trial, inclusive of the 3 mSv exposure resulting from participation in this study. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study. Significance of a medical exposure will be determined by the investigator.
  • Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
  • Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
  • Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  • History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or neurological or psychiatric disorder, as judged by the investigator
  • Presence or history of seizure disorders or ataxia
  • History of presence of significant cardiac conduction abnormalities including but not limited to: PR interval >240 msec; QRS duration >120 msec; QTcF interval >450 msec
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration (See Section 11.4). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
  • Failure to satisfy the investigator of fitness to participate for any other reason

Trial locations and contacts

1 site in 1 country.

Ravi Anand, MD contact

+41 793741364

ravi@anand.ch

United Kingdom1 site, 1 recruiting

  • Quotient Sciences

    Nottingham, NG

    Sharan Sidhu, MRCS

    +44 (0)115 974 9000

    Recruiting

Other trials in United Kingdom

About this study

Official title: An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-NW-3509 in Healthy Male Subjects

This is a single-center, open-label, non-randomized, single dose of 14C-NW-3509 capsule study in 6 healthy male subjects.

Read the detailed description

This is a single-center, open-label, non-randomized, single dose study in a single cohort of 6 healthy male subjects, including up to 2 cytochrome P450 (CYP)2D6 poor metabolizer subjects. Each subject will receive a single oral administration of 14C-NW-3509 capsule in the fasted state.The screening period and study admission to completion is estimated to be up to 43 days. The following data will be analyzed urine and feces data for total radioactivity, plasma and whole blood data for total radioactivity and plasma concentration data for NW-3509.

Conditions
Healthy
Being tested
Evenamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EvenamideDrug

    This is an orally available small molecule that potently blocks voltage-gated sodium channels (VGSCs) in vitro and is indicated for the treatment of patients with schizophrenia, mania, and bipolar disorder.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolic profiling for NW-3509 will be determined in plasma, urine and fecal samples

    Percent of each radio labeled drug-related material will be determined in plasma, urine and feces

    Measured: 15 days

Secondary outcomes (4)

  1. Routes and rate of elimination of NW-3509 in plasma, urine and feces

    The routes and rate of elimination of 14C-NW-3509 by measurement of 14C-NW-3509 and its major metabolites in plasma, urine and feces

    Measured: 15 days

  2. The identification of major metabolites of NW-3509 in plasma, urine and feces

    Metabolic profiling will be performed using liquid chromatography-radio-detection, with subsequent mass spectrometry

    Measured: 15 days

  3. Safety and Tolerability of NW-3509

    This will be assessed by Adverse events, Clinical chemistry, Clinical Hematology and Urinalysis, Vital signs and Physical Examination

    Measured: 15 days

  4. Oral Pharmacokinetics of NW-3509 in plasma, urine and feces

    Several parameters will be measured Cmax, Tmax, AUC, elimination half-life, Tlag etc

    Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2018
  2. Study start2 Apr 2018
  3. Primary completion23 Apr 2018
  4. Study completionJun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03446274
Sponsor's protocol ID
NW3509-007
Status last verified
Jun 2018
First submitted
29 Jan 2018
Last updated
19 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Evenamide in people with Healthy, run by Newron Pharmaceuticals SPA at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ravi Anand, MD (+41 793741364, ravi@anand.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolic profiling for NW-3509 will be determined in plasma, urine and fecal samples (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03446274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.

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